Using sleep study data to predict airway collapse in sleep apnea patients
Prediction of Drug-Induced Sleep Endoscopy Outcome From Baseline Diagnostic Data Including Polysomnography
This study is trying to see if sleep study data can help predict where the airway collapses in people with sleep apnea to improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem) |
| Trial ID | NCT05267808 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop predictive models for the site of airway collapse in patients with obstructive sleep apnea (OSA) using baseline polysomnography data. It will involve 1000 patients who have undergone a recent polysomnographic study and will receive drug-induced sleep endoscopy (DISE) as part of their standard care. The study will analyze airflow shape patterns from polysomnography to correlate with DISE results, ultimately creating models to identify the site, pattern, and degree of upper airway collapse. The first phase will validate a preliminary model in 300 patients to assess its predictive accuracy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with obstructive sleep apnea who are eligible for drug-induced sleep endoscopy.
Not a fit: Patients with central sleep apnea, unstable clinical status, or those with certain psychiatric or medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and treating obstructive sleep apnea by providing critical information on airway collapse patterns.
How similar studies have performed: Preliminary analyses in previous research have shown promise in using airflow patterns to predict airway collapse, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older. * Diagnosis with OSA (AHI ≥ 5). * Eligible for drug-induced sleep endoscopy as the next step in the clinical path for OSA. * Capable of giving informed consent. Exclusion Criteria: * Diagnostic polysomnography data not available at the Antwerp University Hospital. * Factors indicative of unstable clinical status or would preclude DISE investigation: * Medication use related to sleeping disorders. * Central Sleep Apnea Syndrome. * Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy). * Seizure disorders. * Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient). * Pregnancy or willing to become pregnant
Where this trial is running
Edegem
- Antwerp University Hospital — Edegem, Belgium (Recruiting)
Study contacts
- Principal investigator: Olivier M Vanderveken, MD, PhD — University Hospital, Antwerp
- Study coordinator: Sara Op de Beeck, PhD
- Email: sara.opdebeeck@uza.be
- Phone: 0032 3 821 3385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.